Evaluation of Post-SARS-CoV-2 Vaccinal Response in Immunocompromised Patients

Not Applicable

Withdrawn

• Conditions: HIV Seropositivity; Covid19; Vaccination Reaction; Immunodeficiency
• Interventions: Diagnostic Test: Blood draw

• Registration Number: NCT05672654
• Lead Sponsor: University Hospital, Ghent

Brief Summary

The aim of this study is to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients. For antibody detection, LIAISON® SARS-CoV-2 TrimericS assay (DiaSorin) will be used and for the evaluation of cellular immunity - QuantiFERON SARS-CoV-2 assay (QIAGEN).

Detailed Description

The national vaccination campaign against COVID-19 is ongoing and high risk patients are invited. Within the group of high risk patients, there are several groups of people who are for some reason immune-compromised and whose immune system is not functioning adequately. As vaccines against COVID-19 have become available in Europe as a matter of urgency, there are currently insufficient or no data available on the generation of post-vaccinal response in different groups of these immunocompromised patients. The theoretical assumption that the generation of post-vaccinal response in these patients is different from that in immunocompetent individuals is valid, as it has been shown for other vaccines, e.g. against influenza and pneumococcal disease, that the use of immunosuppressive treatments such as asrituximab, methotrexate and rituximab suppress the production of neutralising antibodies. It is known that vaccines against COVID-19 are also capable of inducing a clear functional cellular response in addition to neutralising antibody production, the modalities of which are also insufficiently or not known in these patients.

As mentioned is the goal of VACCIm to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients.

Within this prospective observational study, serum samples (for subsequent measurement with LIAISON® SARS-CoV-2 TrimericS assay) and lithium-heparin whole blood samples (for subsequent measurement with QuantiFERON SARS-CoV-2 assay) will be collected from control immune-competent individuals and immune-compromised patients within the following groups:

* Common variable immunodeficiency disorders and primary immunodeficiency disorders

* HIV-positive patients with CD4 \< 350 cells/mm3

* Immune-compromised patients in rheumatology, neurology and nephrology

In order to assess both humoral and cellular responses as fully as possible, both measurements are performed at the following time points:

T0: before (=prior) or at time of first dose of vaccine T1: 21-28 days after first dose of vaccine T2: at least 10 days after second dose of vaccine T3: after 3 months after second dose of vaccine T4: after 6 months from second dose of vaccine T5: after 12 months from second dose of vaccine

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-05
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Following patient groups receiving the Pfizer vaccine

• HIV-positive patients with CD4 < 350 cellen/mm3
• Common variable immunodeficiency disorders en primary immunodeficiency disorders
• Immune-compromised patients hospitalized at rheumatology/neurology/nephrology

Exclusion Criteria

• patients receiving a different of vaccine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Blood draw	-
HIV positive CD4<350 cells/mm^3	Blood draw	-
Immune-compromised patients- department neurology	Blood draw	-
Immune-compromised patients- department nephrology	Blood draw	-
Primary immune deficiency en common variable immunodeficiency	Blood draw	-
Immune-compromised patients- department rheumatology	Blood draw	-

Primary Outcome Measures

Name	Time	Method
Cellular immune response	prior or at the time of first dose of vaccine until 12 months after second dose of vaccine	DetectionINF-gamma by functional CD4+ and CD8+ cells
Humoral immune response	prior or at the time of first dose of vaccine until 12 months after second dose of vaccine	Detection of Antibodies

Trial Locations

Locations (1)

UH Ghent; 🇧🇪 Ghent, East Flanders, Belgium